Open-ended online discussions on the post-2020 Implementation Plan for the Cartagena Protocol on Biosafety

Dear participants,

In this thread, I invite you to post any comments you may have on the goals of the draft Implementation Plan.

Guiding questions you may wish to consider in this regard are:
- Do the goals of the draft Implementation Plan cover all areas that should be included?
- Do the goals reflect an adequate balance between ambition and pragmatism?
- Is the sequence and division of goals adequate?

Best wishes,
Galina Mozgova

Dear colleagues,
The goals listed under “enabling environment” are fine. No comments to those.

However I have some remarks with respect to the goals listed in the draft Implementation Plan under “areas for implementation”:
Even if it is clear that the list does not prioritize the goals, I think it would be beneficial for the users of the document to have a more logical order, i.e. first goals related to obligations under the protocol followed by more technical issues. Therefore I suggest rearranging the goals as such: 1, 9, 8, 4, 2, 3, 5, 6, and 7.

Furthermore I suggest introducing two new goals (in the list suggested above between 2 and 3, one referring to illegal and unintentional transboundary movements and a second one referring to handling transport and identification which probably should be combined with the current goal 3 on detection.

I also have some troubles to understand the logic of goal 6. It seems to me that two issues are combined, which do not belong together (by the way, this is also reflected in the phrasing of the other columns). It is also not on the same level as the other goals, which do either refer to an article of the Protocol or the supplementary protocol. I doubt that such a goal is need at all , as one part is referring to a minor aspect of the Protocol and the other is already covered by other goals (Risk assessment, BCH, UTM, HTPI). Therefore I suggest to delete current goal 6.

With regard to goal 9 I suggest, as this goal is referring to Article 33 of the Protocol, and also to make a clear distinction from the information provided through the BCH, to add at the end of the sentence “…in their National Reports.”

Best regards
Andreas Heissenberger
Environment Agency Austria

Dear colleagues,
thank you very much for the opportunity to indicate possible opportunities for improvement. There are two points I would like to address regarding the Goals of the Draft Implementation Plan:
A: Areas for Implementation, Goal 5:
With “Parties that choose to do so” the voluntary nature of SEC is incorporated in the Outcome of this Goal. For clarity, however, I believe it would be advisable to also acknowledge the voluntary nature of SEC in the wording of the Goal 5 itself.
A: Areas for Implementation, Goal 7:
As the Goals shall describe the “desirable achievements”, I would support the idea to say “All Parties to the Cartagena Protocol are also Parties to the Nagoya Kuala-Lumpur Supplementary Protocol on Liability and Redress” instead of “Increased Number of Parties…”

Best regards,
Nina Duensing
Federal Office for Consumer Protection and Food Safety, Germany

Dear colleagues

Thank you for the opportunity to provide comments on the draft post-2020 Implementation Plan for the Cartagena Protocol. As a general comment, and as a follow up to the suggestions from my colleague Lim Li Lin (#9765), we are of the view that there are currently some missing elements, which need to be included to ensure full implementation of the Protocol, in the context of achieving its objective.

The issues of contained use, unintentional transboundary movements and emergency measures, while in the Strategic Plan 2011-2020, continue to be relevant and should be included in the post-2020 Implementation Plan. These issues also become increasingly important in the light of the new technologies, in particular organisms produced through synthetic biology and organisms containing engineered gene drives.

As many such organisms are currently in research and development stages, the issue of contained use is important, requiring adequate measures and standards for contained use, including for risk assessment, to be in put in place by Parties. We propose that a goal and corresponding objectives, outcomes and indicators be added on contained use.

The issues of unintentional transboundary movements and emergency measures, as well as that of illegal transboundary movements, are also particularly important for organisms containing engineered gene drives, given their propensity to spread, including potentially across national borders. Guidance developed to assist Parties to detect and take measures to respond to unintentional releases of living modified organisms would be helpful in this regard. Also necessary would be systems set up to assist Parties to be able to be notified quickly and to deal rapidly with unintentional transboundary movements. In this regard, we agree with the proposal by Andreas Heissenberger to add an additional goal on illegal transboundary movements, and unintentional transboundary movemenst and emergency measures, and corresponding objectives, outcomes and indicators (#9760, #9762), some details of which we have suggested above.

We also agree with Andreas Heissenberger regarding the addition of a goal and corresponding objectives, outcomes and indicators on handling, transport, packaging and identification (#9760, #9762), as these issues continue to be relevant for the full implementation of the Protocol, in the context of achieving its objective.

The addition of goals, objectives, outcomes and indicators on unintentional transboundary movements and emergency measures, illegal transboundary movements, and handling, transport, packaging and identification complement current goal 3 on detection and identification. They are all necessary and interconnected elements.

Thank you very much, also to our moderator, and I look forward to further discussion.

kind regards,
Lim Li Ching
Third World Network

Dear Colleagues,
Regarding the goals for the areas for implementation (part A) I agree with rearranging the goals as proposed in comment (#9760) by Andreas Heissenberger and I also agree with the addition of new goals for illegal and unintentional transboundary movements and for handling, transport, packaging and identification as proposed by Andreas Heissenberger (#9760) and Lim Li Ching (#9768).
With regard to goal 7 (Increased number of Parties to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress), I am little bit hesitant about the place of this goal in the draft implementation plan. The reason behind it is that the Supplementary Protocol itself is a kind of separate/independent legal framework; therefore it could also have a separate implementation plan. However, I would not support this idea at this stage. My proposal would be to define this goal in a separate “area” or in a “sub-area”, or if the transposal of this goal does not work, it would be advisable to indicate its importance in the introductory part of the draft implementation plan.
Best regards,
Rita Andorkó
Ministry of Agriculture, Hungary

Dear colleagues,
Regarding the Goals of the Draft Implementation Plan, I have following comments:

In my view, Goal 3 would deserve reformulation in order to better cover the issue of handling, transport, packaging and identification. The HTPI is mentioned only in the respective Outcome to this Goal in the current draft.

Similarly, I would like to see the Goal 5 reformulated to put bigger emphasis on voluntary basis of taking into account socio-economic considerations under the CPB.

Best regards

Hana Jirakova
Ministry of the Environment, Czech Republic

Dear Colleagues,
In my opinion, the order of the goals supposed by Andreas [#9760] is much more logical than the current order.
I also want to reiterate the need to address unintended transboundary and illegal movements as already raised by Andreas, Rita  [#9774] and Lim Li  [#9768]. Furthermore it is necessary for all parties to have tools and concepts in place to identify these cases. Plus, management measures to deal with consequential dissemination of not approved LMO are needed.
I am not sure if this all can be met under goal 3 on detection. Therefore I propose to add an additional goal for monitoring of the presence of  unapproved LMO and for the confirmation if the assumptions of the risk assessment can be confirmed.
Concerning the current goal No 6 I would also recommend to delete it. The idea of facilitating the import of certain LMO goes far beyond the objectives of the Cartagena protocol. Not to mention that, depending on the party and its regulations, there are so many more reasons to limit the import of LMO, like adverse effects on health, animal health, the environment, socioeconomics, ethics etc.
Regards
Birgit

Dear colleagues,

We think that the goals, in general, cover all the areas that should be included on the draft of the Implementation Plan. Nevertheless, considering the current state of world biodiversity (the IPBES report), -The Post 2020 Biodiversity plan-, and the global climate crisis, the Implementation Plan should be completely harmonized with the Convention for Biological Diversity and the policies and actions from countries aimed to mitigate climate change effects.

The Goal 2 in the “Areas of Implementation” section (“Parties carry out scientifically sound risk assessments of LMOs, and manage and control identified risks”), should be expressed (and finally achieved) with the spirit and actions of performing risk assessment analyses with a holistic approach and putting at the front the precautionary principle. The risk assessments of LMOs in the Post-2020 Cartagena Protocol era should include socio-environmental (which is an issue that is not sufficiently discussed and developed yet at the Cartagena Protocol), ethical, and ecological aspects that complement the scientific analyses, importantly when considering the accelerated pace of emerging tools, products and applications of the new biotechnologies (i.e. Synthetic Biology) and the future developments of biotechnology that could fall outside the current approach or definition of LMO. 

Since the potential impacts in the environment of the emerging biotechnologies are yet to be known in some of its applications, the effectiveness of the emergency measures takes special importance, especially in regions/countries that are rich in biodiversity (although this applies for every country).
Another very important issue is that the risk assessment analyses should be carried out putting in first place the precautionary principle.

We agree with comments #9760 #9762 #9768 on the addition of another goal, regarding the handling, packaging, and identification of the products of biotechnology. Particularly, the new biotechnologies, and considering in every moment the decisions about the strict confinment conditions for the LMOs with gene drives.

In relation with Goal 5 in the same “Areas of Implementation” section (“Parties are able to take into account the socio-economic considerations when taking decisions on the import of LMOs in accordance with Article 26 of the Protocol”), this is very relevant, considering that LMOs, or products derived from these could have different applications or could be commercialized in different manners in different societies (which have differentiated socio cultural perspectives and expectations). Apart, the socio-economic considerations should take into account the indigenous peoples and local communities, who have been nourishing and protecting biodiversity; so, in this regard, the consent of the indigenous peoples and local communities should be pursued and obtained, and the decisions taken by these groups should be included in the socio-economic considerations aspects for the risk assessment of LMOs prior to its import, handling, transport and utilization of LMOs. We consider that these approaches could complement the way in which the objectives (what must be accomplished to achieve the goal) should be proposed in the Implementation Plan of the Post 2020 Cartagena Protocol.

In general, current and future Biosafety actions and policies should go beyond the narrow assessment of the benefits and costs of the development, implementation and applications of biotechnologies, it also should include additional potential concerns such as Human Rights, or environmental justice.

On the balance between ambition/pragmatism of the goals

Some references argue that the relevance of the international institutions and platforms involved in biotechnology and biosafety are being undermined by the velocity of emergence of biotechnological developments and its applications (1,2,3). Since the current task is to discuss on the Implementation Plan for the Cartagena Protocol Post-2020, we start by assuming that many technological changes progress faster than institutional change (Cartagena Protocol), and the task is also to think on the achievements for the Implementation Plan of the Cartagena Protocol on biosafety Post2020.
In this order, we consider that some of the goals proposed in the draft of the Implementation Plan for the Cartagena Protocol Post-2020 appear to be a little ambitious, nevertheless, they could be refined or adapted if these goals are analyzed and viewed from the perspective of the developing countries (their economies, their socio-economic and cultural characteristics, ethics and expectations), the current scientific and technical capacities, the degree of penetration/implementation of biotechnologies (i.e. LMOs), the policies and budgets for biosafety in developing countries while projecting the above mentioned aspects into the future (2030, 2050).
These aspects should be contrasted with the current (and future) state of biotechnology, taking into account that the vast majority of biotechnological developments arrive from the Global North and is very plausible that this trend will continue in the future. It is worth noting that this condition could preserve or even increase the gap between biotechnological developments and understanding of their principles, applications and purposes (i.e. LMOs), and the action plans and biosafety policies adopted by the developing countries.

Other considerations that should be taken into account to help to define the goals of Implementation Plan for the Cartagena Protocol Post-2020 in a finer manner should be: the progressive convergence of other scientific disciplines and technologies (i.e. Artificial Intelligence, Robotics, Big Data informatics, Blockchain, etc.), the accelerated pace of emergence of new biotechnologies (which may be considered cross-cutting issues to the three objectives of the Convention on Biological Diversity) and its applications.

We consider that the sequence of the goals is adequate, as well as the division of goals, in order to avoid redundancy of the objectives and tasks of the Cartagena Protocol Post-2020

References
1) Oberthur, S. and Gehring, T. (2006) ‘Institutional Interaction in Global Environmental Governance: The Case of the Cartagena Protocol and the World Trade Organization’, Global Environmental Politics 6 (2), pp. 1–31.

2) Pollack, M. A. and Shaffer, G. C. (2009) When Cooperation Fails. The International Law and Politics of Genetically Modified Foods. New York: Oxford University Press.

3) Podevin, N., Devos, Y., Davies, H. V. and Nielsen, K. M. (2012) ‘Transgenic or Not? No Simple Answer! New Biotechnology-based Plant Breeding Techniques and the Regulatory Landscape’, EMBO Reports, 13 (12), 1057–1061.

Best Regards,
Emmanuel González-Ortega
Inter secretarial Commission on Biosafety of Genetically Modified Organisms (CIBIOGEM), Mexico

Dear all,

I humbly wish to make my input in this ongoing discussion under this thread.
Goal 3; of this Implementation Plan in my opinion should include labelling, for proper detection of LMOs. This will enable parties to follow identification, handling, and packaging including transport requirements more diligently in accordance with the protocol.
In Goal 6: (Parties identify LMOs or traits that may have adverse effects and those that are unlikely to have adverse effects on biological diversity and take appropriate measures) is particularly unique in addressing traits that may have effects on biological diversity and development.
I also suggest that Goal 4B of the Implementation Plan should rather read; ‘‘Cooperation by Parties on Biosafety issues at the national, regional and international levels is enhanced and encouraged to stimulate South-South innovation exchange and technology transfer through social enterprises. This aims at enhancing the participation and facilitating the roles / contributions of non-Parties and other relevant stakeholders such as the NGOs for a more effective implementation of the convention so to speak.

With best regards,

Edel-Quinn Ijeoma Agbaegbu
Every Woman Hope Centre, Nigeria

As supported in posts [#9780], [#9778] and [#9783],  I am writing to make a suggestion to the goal (and objectives) relating to socio-economic considerations in decision-making on import of LMOS (A.5.).  As Article 26 of the Biosafety Protocol is permissive in nature, (“The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity…”), we suggest that the language in Goal A.5. be edited to reflect this fact.  Specifically, we suggest an edit to this goal that would add in this element to make it clear this is not mandatory for all Parties, such as “Parties THAT CHOOSE TO DO SO are able to take into account socio- economic considerations when taking decisions on the import of LMOs in accordance with Article 26 of the Protocol.”  This edit makes it clear that Parties “may” take socio-economic considerations into account, but are not “required” to do so. In addition, the accompanying objective A.5.1 should be edited to highlight that socio-economic considerations are specific to country needs and priorities, and we suggest an edit that adds, “5.1. Parties have access to appropriate guidance materials for taking into account socio- economic considerations in accordance with Article 26 of the Protocol AND CONSISTENT WITH NATIONAL NEEDS AND PRIORITIES.”
Kind regards
Karen Holt

Thank you for having prepared this well structured document and for the opportunity you give me to share my comments through this online forum
1- Goals:
a. As the goals are derived from the fulfilment of relevant articles of the protocol, it would be good to highlight in the formulation of each goal, the corresponding article. This will help readers and users to link each goal to the legal obligation from the protocol.
b. Liking the goal to the article will also help to follow a chronology of the goal based on the relevant article from which it is derived.
c. the area of implementation (A) seems be missing one goal, derived from the article 5 of the protocol on pharmaceutical products. This is very important as a consequence of the goal 3 in case detected LMOs are pharmaceutical. I suggest then the following additional goal:
Goal N°xx: Parties have adopted specific frameworks for the use, handling and transboundary movements of pharmaceutical LMOs:
The objectives, outcomes and indicators should then be added.
Best regards

Dear colleagues,
Thank you very much for very interesting discussion and your substantial proposals.

Just very brief remark regarding LMOs which are pharmaceuticals (Article 5).
It states "Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to the making of decisions on import, this Protocol shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organisations."

Best regards,
Galina

Dear colleagues,

About the goals are fine, cover all aspects. However, from my point of view and considering the current global dinamics as effects of climate change and use of new technologies and according with  the Goal 2   should include socio-economic and environmental aspects and incluid another aspects like the risk assessment analyses from the use of new technologies. In this way, at respect with the objetives  it is appropriate to consider aspects like the risk assessment and procedures in the transport of LMOs such as: production processes, transport of LMOs and implementation plans with monitoring and methodologies and sanctions for damages caused by unintentional release.

I think too that it is necessary to consider other aspects such as organisms derived from new technologies especially the products from crops created with new technologies . In addition, we need to include aspects such as the Conservation of native biodiversity for preservation of genetic variability that is a fundamental tool to respond to environmental changes.

I agree with the comment (#9787) about the potential impacts in the environment of the emerging biotechnologies because are not clear some applications, I think that we need focus on the effectiveness of the emergency measures takes special importance, especially in countries that are rich in biodiversity like Mexico.

Best regards
Mariana Ayala
Biosafety Subdirection, INECC, Mexico City.

Dear colleague,
Thank you for the opportunity to comment on the draft post-2020 Implementation Plan for the Cartagena Protocol on Biosafety. My comment is on socio-economic considerations, that Parties should be given a free hand in formulating their own guidelines, in accordance with the Protocol's objectives, taking into account the country's domestic laws and interests, and when in the GM product development stage the socio-economic considerations will be applied.

Best regards,
Ma. Lorelie Agbagala
Asst. Scientist
DOST, Philippines

Dear moderator and dear forum participants, thank you for the opportunity to provide feedback on the draft Implementation Plan for the Cartagena Protocol. My contribution specifically addresses some proposed additional goals that were shared on this forum.

We strongly support the approach taken in the draft implementation plan to “avoid redundancy and duplication and to focus on smaller number of achievable goals”.

Proposals have been made here to include specific goals for “new technologies” and for “contained use”, and these would be examples of redundancy and duplication that the implementation plan is aiming to avoid.

We support the pragmatic approach that has been taken in this Implementation Plan, as explained in paragraph 18 of the Draft Implementation Plan document: “organisms developed through new technologies constitute ‘living modified organisms’ as defined in the Protocol, and as such they are already addressed in the Plan.” This reflects the outcomes of work programs to date under both the Convention and the Protocol that living organisms resulting from “new technologies” are LMOs.

The proposal to develop a specific goal and associated objectives on contained use, would also be a clear example of duplicative effort. Further, contained use is not in the scope of the Protocol (Article 6 paragraph 2). Contained use is a long-established field, predating LMO biosafety, with other bodies that have authority in the area of contained use regulations and practice.  This field is supported by extensive and robust international, regional and national regulations and guidance for the handling, storage, containment measures, waste management, transport, packaging and identification of biological organisms under contained use, including LMOs, to ensure the protection of human health and the environment. The principles of containment that apply to human, animal and plant pathogens transferable to different types of organisms, including LMOs. It would be redundant and duplicative, as well as beyond the scope of the Protocol to initiate work on this topic.

For a list of relevant resources on biosafety in containment, please consult the attached document.

With kind regards,
Ana Atanassova
EuropaBio

Dear moderator and fellow participants,

Thank you for the (extended) opportunity to comment on the Implementation Plan. I wish to comment specifically on Goal 6, and agree with others (#9778, #9783, #9792, #9809, #9810) that have supported retaining the reference to LMOs that are “unlikely to have adverse effects”. This is best placed within Goal 6, and this should be retained for several reasons:
- It is consistent with the Protocol itself – the Protocol is intended to apply to LMOs “that may have adverse effects” (Objective - Article 1; Scope – Article 4; Application of the Advance Informed Agreement Procedure – Article 7) – hence its implementation should be focussed on such LMOs.
- It is consistent with incorporating “new elements reflecting lessons learned…” in the post-2020 Implementation Plan. “Lessons learned” are evident in the large number of decisions contained in the BCH and the extensive body of scientific literature on the topic of LMO risk assessment. This corpus of evidence demonstrates that many LMOs have been released into the environment without adverse effects, some of which are widely commercialized LMOs with long histories of safe use.
- It is consistent with “ensur[ing] sufficient flexibility to account for developments…”. Such developments would include knowledge about LMOs.
- It supports the intention of focussing implementation and avoiding redundancy and duplication.

Also in regard to Goal 6, I agree with the comments in #9770 that liability is more appropriately addressed under Goal 7.

Kind regards,
Felicity Keiper